GMP News and Articles
Read our articles on pharmaceutical GMP regulatory developments as well as news about our pharmaceutical training courses. The 5 most recent GMP news articles are shown in the slider and the rest are shown in date order below.
If you have some GMP news you would like us to publish then please contact us.
Chapter 3 of European Union Good Manufacturing Practice (EU GMP) has been updated and came into operation on 1st March 2015. This post summarises the main changes.
Hot off the press – find out more about new guidance from the MHRA on GMP data integrity expectations for the pharmaceutical industry.
The European Union’s guidelines on Good Distribution Practice (GDP) were updated at the end of 2013. This post covers an overview of the main differences between GDP and Good Manufacturing Practice (GMP).
It is no longer clear in GMP exactly who should review batch records!
A summary of the requirements of the new EU GMP Chapter 6 – Quality Control
A new update to EU GMP Chapter 2 has been issued and comes into operation on 16th February 2014. Here is a summary of the main changes.
Interactive and thought provoking classroom and online GDP and GMP training courses facilitated and developed by Pharma experts with great training abilities
Global projects successfully undertaken for some of the largest Pharma businesses
I have been working with two multinational pharmaceutical companies recently and both have Corporate GMP requirements that all personnel have a copy of their Curriculum Vitae (CV), or résumé (if you are on the other side of the Atlantic), in individual’s training records. This at first seems a reasonable and simple requirement to implement – but I have seen a number of problems and a solution that may be of interest.
Just a reminder that the new EU GMP Chapter 1 on Pharmaceutical Quality Systems and Chapter 7 on Outsourced Acticities come into operation today (31st January 2013). To read my posts on these from last year and to see in actual text click on the links. If you need...
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